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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name single-use reprocessed ultrasonic surgical instruments
510(k) Number K111794
Device Name REPROCESSED HARMONIC SCALPEL
Applicant
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369 -5562
Applicant Contact ONYA DENDINGER
Correspondent
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369 -5562
Correspondent Contact ONYA DENDINGER
Classification Product Code
NLQ  
Date Received06/27/2011
Decision Date 01/11/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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